DenBite

GUDID 08717228440090

X-Ray sensor holder Introduction Pack Size 1, content: 1x bitewing - UDI 08717228441035 1x posterior Upper Left / Lower Right - UDI 08717228441554 1x posterior Upper Right / Lower Left - UDI 08717228441561 1x periapical Upper Left / Lower Right - UDI 08717228441233 1x periapical Upper Right / Lower Left - UDI 08717228441240 1x endo Upper Left / Lower Right - UDI 08717228441196 1x endo Upper Right / Lower Left - UDI 08717228441202 1x positioning ring - UDI 08717228441028

DuPhaMed B.V.

Dental x-ray film holder, reusable

• Primary Device ID: 08717228440090
• NIH Device Record Key: 588c7e08-7d25-46fb-b51d-a78dcd79a268
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DenBite
• Version Model Number: DBU2061
• Company DUNS: 413491023
• Company Name: DuPhaMed B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717228440090 [Primary]

FDA Product Code

• EGZ: Holder, Film, X-Ray

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08717228440090]

Moist Heat or Steam Sterilization

[08717228440090]

Moist Heat or Steam Sterilization

[08717228440090]

Moist Heat or Steam Sterilization

[08717228440090]

Moist Heat or Steam Sterilization

[08717228440090]

Moist Heat or Steam Sterilization

[08717228440090]

Moist Heat or Steam Sterilization

[08717228440090]

Moist Heat or Steam Sterilization

[08717228440090]

Moist Heat or Steam Sterilization

[08717228440090]

Moist Heat or Steam Sterilization

[08717228440090]

Moist Heat or Steam Sterilization

[08717228440090]

Moist Heat or Steam Sterilization

[08717228440090]

Moist Heat or Steam Sterilization

[08717228440090]

Moist Heat or Steam Sterilization

[08717228440090]

Moist Heat or Steam Sterilization

[08717228440090]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-04
• Device Publish Date: 2023-11-24

On-Brand Devices [DenBite]

• 08717228440762: Wallmount basket for digital sensors, size1 and 2, white
• 08717228440755: Wallmount basket for digital sensors, size 1 and size 2, black
• 08717228440151: Phosphor Plate Holder Introduction Pack, content: 2x bitewing - UDI 08717228440243 2x posterior
• 08717228440779: Bite block sleeves PE Small
• 08717228440106: X-Ray sensor holder Introduction Pack Size 2, content: 1x bitewing - UDI 08717228441042 1x post
• 08717228440090: X-Ray sensor holder Introduction Pack Size 1, content: 1x bitewing - UDI 08717228441035 1x poste
• 08717228440083: X-Ray sensor holder Refill Pack Endo Size 2, Content: 3x endo Upper Left / Lower Right - UDI 087
• 08717228440076: X-Ray sensor holder Refill Pack Endo Size 1, Content: 3x endo Upper Left / Lower Right - UDI 08
• 08717228440069: X-Ray sensor holder Refill Pack Periapical Size 2, Content: 5x periapical Upper Left / Lower Ri
• 08717228440052: X-Ray sensor holder Refill Pack Periapical Size 1, Content: 5x periapical Upper Left / Lower Ri
• 08717228440045: X-Ray sensor holder Refill Pack Posterior Size 2, Content: 5x posterior Upper Left / Lower Right
• 08717228440038: X-Ray sensor holder Refill Pack Posterior Size 1, Content: 5x posterior Upper Left / Lower Righ